Latest Rapid Diagnostic Testing News

Lumos Diagnostics reported a 6% revenue increase to US$13.2 million for FY26, driven by an 875% surge in FebriDx® sales following a pivotal CLIA waiver. The company expanded U.S. adoption to 170+ healthcare sites and secured milestone payments exceeding US$6 million.

Lumos Diagnostics is accelerating the rollout of its rapid FebriDx test in the US, with a top 100 urgent care group deploying across 30+ sites and three tier 1 groups validating the test across 230+ locations.

Atomo Diagnostics has closed a modest Share Purchase Plan, raising $44,500 and issuing free attaching options, while reserving a substantial shortfall for future placement.

Lumos Diagnostics has secured a key FDA 510(k) clearance with CLIA waiver for its FebriDx rapid test, unlocking a US$1 billion-plus market opportunity and triggering milestone payments exceeding US$6 million. The company reported a 37% revenue jump in Q3 FY26, supported by a A$20 million placement and ongoing clinical and development projects.

Lumos Diagnostics has secured its largest-ever order for FebriDx® following FDA clearance, signalling a major expansion in the US market opportunity.

Atomo Diagnostics stands to gain significantly as Lumos Diagnostics’ FebriDx test secures FDA CLIA waiver approval, vastly expanding its US market potential. This regulatory milestone triggers substantial contracted revenues and prompts Atomo to ramp up production.

Nexsen Limited is advancing its rapid Group B Streptococcus test, StrepSure®, with a clear FDA submission timeline and early market entries across Asia-Pacific and emerging regions.

Atomo Diagnostics has secured a substantial A$416,000 order for its HIV Self-Test kits destined for an African country, marking its second Global Fund-backed contract this year and signalling growing global demand.

Atomo Diagnostics has landed a significant $502,000 order for HIV self-tests destined for an African country, underscoring sustained demand for accessible diagnostics in the region.

Lumos Diagnostics has achieved a major milestone by securing 100% Medicare reimbursement recognition for its FebriDx test across all seven US Medicare Administrative Contractors, paving the way for broader adoption in the American healthcare system.

Atomo Diagnostics reports a significant expansion in its supply agreement with Lumos for the Pascal test cassette, tied to the promising CLIA waiver status of the FebriDx test in the US. This deal could nearly double Atomo’s revenues over the next three years.

Lumos Diagnostics has submitted its CLIA waiver application for FebriDx® to the FDA, backed by strong clinical data and triggering significant milestone payments. Approval could expand the U.S. market opportunity fifteen-fold to over $1 billion.